MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	10373
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported thrombus occurred.A left atrial appendage (laa) closure procedure was being performed.The patient had been taking warfarin and their international normalized ratio (inr) was therapeutic on the day of the implant.The trans-septal puncture was performed and the watchman access system (was) was inserted into the patient.It was noticed that there was a large clot in the right side of the heart near the septum attached to the was.Heparin had been administered and the activated clotting time (act) measured 399 seconds.The clot was aspirated out.The was was removed and a new was was used to continue the procedure.A watchman laa closure device was successfully implanted in the patient.There were no patient complications and the patient has since been discharged from the hospital.

• Brand Name: WATCHMAN ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11003055
• Report Number: 2134265-2020-17271
• Device Sequence Number: 16319477
• Product Code: NGV
• UDI-Device Identifier: 08714729838203
• UDI-Public: 08714729838203
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0025268833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention